Safety and Efficacy of a Hypoglossal Nerve Implant for the Treatment of Obstructive Sleep Apnea (OSA)

Not Applicable

Completed

• Conditions: Sleep Apnea, Obstructive; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Respiration Disorders; Syndrome, Obstructive Sleep Apnea

• Registration Number: NCT01532180
• Lead Sponsor: ImThera Medical, Inc.

Brief Summary

The objective of the study is to determine the safety and preliminary efficacy in patients utilizing the aura6000 System for the treatment of Obstructive Sleep Apnea (OSA).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Study First Submitted: 2012-02-09
• Study First Submitted QC: 2012-02-09
• Study First Posted: 2012-02-14
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-08
• Last Update Posted: 2019-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Moderate to severe obstructive sleep apnea (AHI 15 to 60).
• Cannot or will not tolerate CPAP treatment.
• Body mass index (BMI) between 25 and 40
• Able to read, understand, sign and date the written informed consent form

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Adverse events and Serious Adverse events peri and post-operatively	3 and 12 months post-operative
Mean change in AHI measured through in-lab polysomnography (PSG) compared to baseline.	3 and 12 months post-implant

Secondary Outcome Measures

Name	Time	Method
Mean change in Quality of Life outcomes measured with FSS (Fatigue Severity Scale) as compared to baseline.	3 and 12 months post-implantation
Mean change in Quality of Life outcomes measured with ESS (Epworth Sleepiness Scale) as compared to baseline.	3 and 12 months post-operative

Trial Locations

Locations (1)

Clinique Univ. Saint-Luc; 🇧🇪 Brussels, Belgium